Kornimate/medical-research-clean huggingface dataset:
ingenol mebutate compared to cryotherapy for the treatment of skin lesions

Conditions: Actinic Keratosis

Summary: the purpose of this study is to find out the effectiveness of ingenol mebutate compared to cryotherapy (freezing of the tissue) for the treatment of face and scalp skin lesions.


Eligibility criteria:
inclusion criteria: * male and female subjects between 18 and 89 years old. * have at least a total of 10 non-hypertrophic actinic keratoses (aks) on the face and scalp * the subjects are in good health * the subjects have the willingness and the ability to understand and provide informed consent for the use of their tissue and are able to communicate with the investigator exclusion criteria: * subjects under 18 years of age and over the age of 89 * subjects who are pregnant or lactating * subjects with sensitivity to cold * subjects with use of topical medications such as corticosteroids, alpha-hydroxyacids or retinoids 2 weeks before study entry * subjects who received previous treatment of target aks * subjects whose target treatment area was within 5 cm of an incompletely healed wound or within 10 cm of a suspected basal-cell or squamous-cell carcinoma * subjects with use of medications or other treatments that could interfere with evaluation of the treatment area within 2 months before study entry (e.g., topical medications, artificial tanners, immunosuppressive medications, immunomodulating agents, cytotoxic drugs, ultraviolet b phototherapy, other therapies for actinic keratoses, or oral retinoids) * subjects who are unable to understand the protocol or to give informed consent
study on the oxygen saturation in pulsating and non-pulsating central retinal veins

Conditions: Open Angle Glaucoma; Normal Tension Glaucoma

Summary: retinal ischemia is thought to play an important role in the pathogenesis of glaucoma. recent findings have confirmed that there is a direct correlation between the levels of venous oxygen saturation and the degree of the glaucomatous disease, presumably due to a decrease in retinal cell metabolism. however, glaucoma patients have been suggested to have a different pattern in retinal venous circulation. for instance, the observation of a visible pulsating central retinal vein is a phenomenon that can be seen in up to 98% of the healthy individuals but is identifiable in less than 50% of glaucoma patients. while the nature of these venous changes are not year clear, the lack of a visible pulsating flow could suggest an increased intraluminal venous pressure due to some obstruction from both ocular or extraocular structures. this undetermined increase in venous pulse pressure could then significantly decrease perfusion pressures and therefore further decrease oxygen supply to the retinal tissues. the investigators will therefore try to determine if there is a significant difference between the oxygen saturation of the retinal vessels in both glaucoma patients with and without a visible pulsating central vein

1. visual field examen will be performed. 2. structural examination of the optic disc (confocal microscopy) will be performed. 3. spontaneous venous pulsation will be recorded after a one minute fundoscopy observation. 4. oximetry reading in the non-contact retinal oximetry of the first 3 order retinal vessels

Eligibility criteria:
inclusion criteria: * individuals over 18 years old * willing to sign an informed consent and able to comply with the requirements of the study * having no other ocular diseases besides glaucoma exclusion criteria: * history of ocular trauma * intraocular surgery (except for cataract surgery) * eye disease (except glaucoma) * systemic diseases with ocular involvement like diabetes
effect of memantine oral pump on language in patients with probable alzheimer's disease

Conditions: Alzheimer's Disease; Dementia

Summary: this study will evaluate the pharmacological efficacy on language capability and compliance with combination of new ebixa oral pump and donepezil compared to donepezil only in patients with probable alzheimer's disease. primary objective is to evaluate the efficacy of memantine on language capability in moderate to severe alzheimer's disease patients who are taking stable donepezil treatment.secondary objectives are to evaluate the efficacy of maintain on cognitive function and disease progression with k-mmse, npi, rosa, and sib-short form in probable ad.


Eligibility criteria:
inclusion criteria: * probable alzheimer's disease in accordance with nincds-adrda criteria * mmse score equal to or less than 20 * brain ct or mri scan performed within the past 12 months * living or having regular visit at least three times a week from caregiver * able to visit outpatient clinic and to perform cognitive function test * already taking stable dose of donepezil for 3 months prior to screening * subject and caregiver who signed informed consent exclusion criteria: * involved in another clinical trial within 4 weeks prior to screening * severe or unstable disease: acute or severe asthma, unstable or severe cardiovascular disease, acute peptic ulcer,chronic renal failure * bradycardia (pulse rate less than 50bpm), sick sinus syndrome * any laboratory finding including cognitive impairments(vitamine b12 or folic acid, syphilis, thyroid disease) * severe auditory or visual disturbance * other degenerative disease or psychosis * taken any drug used for the treatment of alzheimer's disease or dementia
testing of a candy in five different versions for the additional humidification of the oral cavity

Conditions: Xerostomia; Dryness of Mouth

Summary: this study is to investigate whether a candy can increase moisture of the oral cavity and reduce dryness of mouth.

a candy (available on the market from a swiss manufacturer (ricola)), free of ingredients that could interfere with the investigation, is tested in five different versions on different days. it is to analyse whether these candies can increase moisture of the oral cavity and reduce dryness of mouth.

Eligibility criteria:
inclusion criteria: * non- smoker * no allergies * no drug- use (except for contraception) * healthy volunteers (no disease/infection 4 weeks before study participation) exclusion criteria: * pregnant women

Keywords: salivary flow rate salivary flow stimulation
effect of passive ultrasonic irrigation on the reduction of bacteria and endotoxins in root canals

Conditions: Tooth, Nonvital

Summary: the purpose of this clinical study was to compare the effectiveness of passive ultrasonic irrigation with that of traditional syringe irrigation on the removal of bacteria and endotoxin (lipopolysaccharide \[lps\]) from root canals.

forty teeth with apical periodontitis were randomly allocated into two groups according to the irrigation protocol, passive ultrasonic irrigation (pui, n = 20) and syringe and needle irrigation (ni, n = 20). microbiological sampling was performed before (s1) and after the root canal preparation (s2), after the tested irrigation protocols (s3). total bacteria counts were determined by a quantitative pcr (qpcr) assay; and the endotoxin levels by the lal assay.

Eligibility criteria:
inclusion criteria: * teeth with necrotic pulps and asymptomatic apical periodontitis exclusion criteria: * patients who had received antibiotics during the previous 3 months or had any general disease, * teeth that could not be properly isolated with rubber dam, * non-restored teeth, * periodontal pockets depths greater than 4 mm, * previous endodontic treatment, * open apex, * crown/root fracture * root resorption or calcifications.

Keywords: bacterial infection endotoxin passive ultrasonic irrigation root canal treatment
astigmatism management in cataract surgery with the acrysof toric intraocular lens

Conditions: Astigmatism

Summary: the purpose of this study is to determine if toric intraocular lens implantation in cataract surgery is a more efficient and cost-effective treatment of astigmatism than monofocal intraocular lens implantation.

a recent innovation in cataract surgery consists of the introduction of toric intraocular lenses (iols) that can correct corneal astigmatism. it offers the opportunity for patients with substantial astigmatism to achieve optimal distance vision without using spectacles. good near vision may subsequently be achieved with low-cost reading glasses. the current practice of non-toric iol implantation in astigmatic patients warrants the use of expensive bifocal or multifocal spectacles with cylinder correction to achieve good distance and near vision. objective: the primary objective of this study is to compare spectacle independence for distance vision following toric iol implantation and monofocal intraocular lens (iol) implantation. the secondary objectives are to compare uncorrected distance vision, residual refractive astigmatism, quality of vision, wavefront aberrations, contrast sensitivity, complication profile, costs of postoperative spectacles and cost-effectiveness. study design: multi-centre randomised clinical trial. study population: 160 patients with regular corneal astigmatism of at least 1.25 diopters in both eyes who require bilateral cataract surgery. intervention: cataract surgery with implantation of a toric iol (acrysof model sn60tt) or an monofocal iol (acrysof model sn60at).

Eligibility criteria:
inclusion criteria: * bilateral cataract * bilateral corneal astigmatism (at least 1.25d) * predicted residual astigmatism less than 0.5d exclusion criteria: * irregular corneal astigmatism or keratoconus * fuchs endothelial dystrophy (stage 2) * expected postoperative best-corrected visual acuity worse than logmar +0.3

Keywords: corneal astigmatism intraocular lens
mr antagonist and lsd1

Conditions: Hypertension; Mineralocorticoid Excess

Summary: lysine specific demethylase-1 (lsd1) is an epigenetic regulator of gene transcription involved in the pathophysiology of elevated blood pressure and likely renal damage in blacks. this project investigates whether a genetically driven anti-hypertensive approach proves superior in controlling blood pressure and mitigating renal injury in blacks who carry the risk allele for lsd1 (rs587168). the findings of these investigations may lead to a new approach in treating a subset (\~30%) of the essential hypertension population (black lsd1 risk allele hypertensives).

this proof-of-principle physiologic study in hypertensive black lsd1 risk allele carriers testing the hypothesis that reductions in blood pressure will be greater with a genetically-driven anti-hypertensive approach (mineralocorticoid receptor antagonist, eplerenone) compared to a non-specific approach (amlodipine). 56 participants will be enrolled in a 12-week randomized, double-blind, active controlled, outpatient study to assess whether eplerenone (lsd1 specific treatment) proves superior in 24-hr ambulatory systolic blood pressure reduction than amlodipine (non-specific treatment). participants will be randomized to either eplerenone 50mg or amlodipine 2.5mg with escalations in dose of study drug every 4 weeks if the participant's blood pressure is \> 140/90.

Eligibility criteria:
inclusion criteria: * untreated as well as currently treated hypertensives * rs587168 allele carriers * not on more than two anti-hypertensives * normal renal, metabolic, electrolyte, and cbc laboratory tests * self-identified black race * age \>17 yrs. exclusion criteria: * known cardiac disease other than htn * renal, circulatory or neurologic diseases * diabetes * smoking * secondary htn as indicated by history, physical examination or screening blood and urine tests * smoking * any drug therapy, except for anti-hypertensives and stable thyroid medication replacement
utility of disconnection technique for one lung ventilation

Conditions: Pneumothorax

Summary: lung isolation technique is useful for lung or heart surgeries for better visualization. double lumen endobronchial tube and bronchial blocker are available for lung isolation. adding disconnection technique before lung isolation is helpful to accelerate the lung deflation. however, the utility of disconnection technique has never been evaluated in comparison of double lumen tube and bronchial blocker. therefore, the utility of disconnection technique in two different lung isolation technique, double lumen tube and bronchial blocker will be evaluated


Eligibility criteria:
inclusion criteria: * patients scheduled for wedge resection for pneumothorax, unilateral * asa class i, ii exclusion criteria: * know lung disease * any kind of lung abnormality on preoperative chest x-ray * coronary artery occlusive disease * cerebrovascular disease * pregnancy * unable to understand the informed consent form
electronic health record-integrated patient-generated data

Conditions: Sepsis

Summary: the purpose of this study is to find out if patients that receive supportive messaging with response adaptation are more likely to adhere to patient-generated data collection and electronic health record integration, compared to patients that do not receive supportive messaging.

this project will directly inform re-usable strategies to support the integration of important patient-generated data (pgd) into the electronic health record to improve clinical care and research. for this application, investigators propose to develop and test the pgd translational science innovation in patients recovering from sepsis. this diverse patient population frequently suffers from long-term complications that are ideally suited for development and demonstration of strategies to collect, integrate, and examine pgd and builds directly on the study team's robust research portfolio on improving sepsis recovery.

Eligibility criteria:
inclusion criteria: * discharged alive from the hospital without hospice care who meet clinical criteria for infection and organ dysfunction consistent with sepsis * enrolled into the sepsis transition and recovery program * enrolled or willing to enroll as an epic mychart user exclusion criteria: * discharged from the hospital with hospice care

Keywords: patient-generated data collection electronic health record monitoring transitional care
study to compare the pharmacokinetic characteristics and safety of dilatrend sr capsule 32mg and dilatrend tablet 25mg

Conditions: Essential Hypertension; Chronic Stable Angina; Congestive Heart Failure

Summary: the purpose of this study is to compare the pharmacokinetic characteristics and safety of dilatrend sr capsule 32mg and dilatrend tablet 25mg in healthy male subjects.

healthy male subjects are administrated multiple-dose over the period i and ii (crossover) of dilatrend sr capsule 32mg and dilatrend tablet 25mg.

Eligibility criteria:
inclusion criteria: * between 20 aged and 35aged in healthy male * body weight more than 50kg, and within 20% of ideal body weight(ibw). * ibw(kg) = {height(cm)-100}\*0.9 * have not any congenital or chronic disease and medical symptoms. * suitable results of inspections(laboratory test, ecg, etc) within 21 days before ip administration. * agreement with written informed consent exclusion criteria: * subject has hypersensitivity reaction or clinically significant history about carvedilol or investigator drug. * clinically significant cardiovascular system, respiratory system, liver, kidney, endocrine system, gastrointestinal system, central nervous system, blood tumor, mental disease, skin disease, otorhinolaryngologic diseases and so on. * hypotension(sbp \ 150mmhg or dbp \> 100mmhg) * heart rate \< 50times/minute * active liver disease or ast, alt \> 1.5\*upper limit of normal range * creatinine clearance \< 80ml/min * subject has a disease affecting drug's adme or gastrointestinal surgery. * subject with symptoms of injured or acute disease within 28days before the first ip administration. * subject has a history of drug abuse or a positive reaction for drug abuse at the screening test for urine. * taking etc medicine including oriental medicine within 14days before the first ip administration or taking otc medicine within 7days * subject takes an abnormal meal which affect the adme of drug. * previously participate in other trial within 90days. * previously make whole blood donation within 60days or component blood donation within 30days before the first ip administration. * continued to be taking caffeine(caffeine \> 5cup/day), drinking(alcohol \> 21unit/week, 1unit = 10g = 12.5ml of pure alcohol) or during clinical trials can not be drunk or severe heavy smoker(cigarette \> 10cigarettes/day). * subject with positive reaction about serum test(hbsag, hcv ab, hiv ag/ab, vdrl) * genetic problems such as galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption. * an impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result.

Keywords: carvedilol dilatrend sr capsule dilatrend tablet pharmacokinetics healthy male subjects
gait, cognition & decline (good)

Conditions: Mild Cognitive Impairment; Mild Dementia; Moderate Dementia; Healthy

Summary: the main objective of the good initiative was to determine which spatio-temporal gait parameters and/or combination(s) of spatio-temporal gait parameters best differentiate between cognitively healthy individuals (chi), patients with mild cognitive impairment (mci) and those with mild and moderate dementia.

gait disorders are frequent in individuals with cognitive disorders. however, the profile of spatio-temporal gait parameters in the different cognitive status in aging (from normal cognition to dementia) has been poorly studied. determining this profile associated with the severity of cognitive disorders may be helpful to understand the complex interplay between gait and cognitive disorders and, thus, may have important implication for the diagnosis process of patients with and without dementia. for instance, defining a motor phenotype of the severity of cognitive disorders by using quantitative gait measurements could be used to improve the prediction and the diagnosis of dementia. the investigators hypothesized that, compared to chi, people with mci and mild dementia could be characterized by specific phenotypes of spatio-temporal gait parameters measured with the gaitrite® system, and that these profiles could be explained by declines in domain-specific cognitive performance.

Eligibility criteria:
inclusion criteria: * being 60 years old and older * ability to answer questions exclusion criteria: * opposition to the use of information collected for research purposes

Keywords: cognitively healthy individuals
laryngeal masks for bariatric surgery

Conditions: Morbid Obesity

Summary: obese people pose specific problems as far as the management of airway during surgery. the study aims to compare efficacy and safety of two lma devices.

the study will investigate two types of lma devices endowed of different constructive features. the two devices share common features as far as providing access to the stomach and reducing morbidity of the upper airway. the two device differ in regard to ease of insertion and sealing of the airway and these features are particularly important in the obese patient.

Eligibility criteria:
inclusion criteria: * asa class i-iii * candidates to bariatric surgery exclusion criteria: * uncontrolled psychiatric symptomatology * known or presumed pregnancy * history of surgery on the airway or esophagus * gastroesophageal reflux

Keywords: anesthesia postanesthetic recovery ventilation bariatric surgery
feasibility and safety of in-bed cycling/stepping in critically ill patients

Conditions: Critically Ill Patient; Intensive Care Unit Acquired Weakness

Summary: intensive care unit (icu)-acquired weakness (icu-aw) is one of the most common complications of post-icu syndrome. it is the leading cause of gait disturbance, decreased activities of daily living, and poor health-related quality of life. the early rehabilitation of critically ill patients can reduce the icu-aw. we designed a protocol to investigate the feasibility and safety of conventional rehabilitation with additional in-bed cycling/stepping in critically ill patients. the study is designed as a single-center, open-label, pilot, randomized, parallel-group study. after the screening, participants are randomly allocated to two groups, stratified by mechanical ventilation status. the intervention group will be provided with exercises of in-bed cycling/stepping according to the level of consciousness, motor power, and function in addition to conventional rehabilitation. in contrast, the control group will be provided with only conventional rehabilitation. the length of the intervention is from icu admission to discharge, and interventions will be conducted for 20 minutes, a maximum of three times per session. the primary outcome is the number and percentage of completed in-bed cycling/stepping sessions, the duration and percentage of in-bed cycling/stepping sessions, and the number of cessations of in-bed cycling/stepping sessions. the secondary outcomes are the interval from icu admission to the first session of in-bed cycling/stepping, the number and percentage of completed conventional rehabilitation sessions, the duration and percentage of conventional rehabilitation sessions, the number of cessations of conventional rehabilitation sessions, the number of adverse events, level of consciousness, functional mobility, muscle strength, activities of daily living, and quality of life. this study is a pilot clinical trial to investigate the feasibility and safety of conventional rehabilitation with additional in-bed cycling/stepping in critically ill patients. if the expected results are achieved in this study, the methods of icu rehabilitation will be enriched.


Eligibility criteria:
inclusion criteria: * age ≥ 45 * admission to icu ≤ 72 hours * patient deemed to need ≥ 48 hours of icu care * premorbid functional ambulation category≥ 2 exclusion criteria: * neurologic disorders i.central nervous system: acute stroke, advanced dementia, hypoxic-ischemic encephalopathy ii. peripheral nervous system: amyotrophic lateral sclerosis, myasthenia gravis, acute inflammatory demyelinating polyneuropathy * acute deep venous thrombosis, pulmonary embolism * pneumothorax * external fixator, superficial metallic implants, amputation, eschar, etc * expected icu discharge within 3 days of admission * pregnant * difficulty in obtaining consent (rejection, no family, if the family does not agree) * if the life expectancy is less than 6 months

Keywords: clinical trial critically ill patient in-bed cycling in-bed stepping intensive care unit
pharmacology of aminophylline for acute kidney injury in neonates

Conditions: Acute Kidney Injury

Summary: acute kidney injury (aki) in critically ill neonates is common and associated with significant morbidity and mortality. no targeted therapeutic treatment strategies have been established for aki in neonates. within a clinical pharmacokinetic and pharmacodynamic conceptual framework, this project will examine the medication aminophylline as a potential treatment approach for aki.


Eligibility criteria:
inclusion criteria: * neonate \< 3 months post natal age * diagnosed with acute kidney injury (aki) * receiving aminophylline for aki treatment as per local standard of care. exclusion criteria: * presence of anatomical renal anomaly based on postnatal evaluation of the patient (hydronephrosis, multicystic kidney, renal agenesis, renal dysplasia, polycystic kidney, or obstructive uropathy) * patient on renal replacement therapy * major genetic abnormalities (trisomy 13, 18 or 21).